Pharmaceutical Regulatory Affairs: Open Access

Hideharu Shintani

Publications

• Review Article
  Sterilization Validation of Gas Plasma Exposure Based on ISO Documents (Mainly ISO TC 198 And 194 Documents)
  Author(s): Hideharu ShintaniHideharu Shintani
  
  There are so many ISO documents to understand and utilize for validation studies and routine control. A biological indicator (BI) is essential for conducting sterilization validation and routine control. ISO 11138-1 and ISO 14161 are the major documents to follow for BI manufacturers and BI users, respectively. In ISO 11138-1, BI manufacturers must utilize a BI with 106 CFU/carrier as an initial population for validation studies. For routine control, it is approved to use an initial BI population of 105 CFU/carrier according to ISO 11138-1. In ISO 14161 BI users need not imitate BI manufacturers and less than 106 CFU/carrier BI is approved for use in validation studies and routine control. According to ISO 14161 for BI users, the initial population must be identical for validation studies and routine control. For the BI user, there are four types of pr.. Read More»
  DOI: 10.4172/2167-7689.1000137

  Abstract PDF